ARC 2414C
PHARMACY BOARD[657]
Adopted and Filed
Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy hereby amends Chapter 6, “General Pharmacy Practice,” and Chapter 8, “Universal Practice Standards,” Iowa Administrative Code.
The amendments implement 2015 Iowa Acts, Senate File 462, which authorizes the prescribing of epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, or an accredited nonpublic school. The amendments exclude such a prescription from the requirement for a preexisting patient-prescriber relationship and establish the unique prescription label and record-keeping requirements for a prescription issued to a facility, school district, or accredited nonpublic school as authorized by 2015 Iowa Acts, Senate File 462.
Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657—Chapter 34.
Notice of Intended Action was published in the December 9, 2015, Iowa Administrative Bulletin as ARC 2288C. The Board received one written comment regarding the proposed amendments. The single comment received expressed support for the proposed amendments. The adopted amendments are identical to those published under Notice.
The amendments were approved during the January 13, 2016, meeting of the Board of Pharmacy.
After analysis and review of this rule making, no impact on jobs has been found.
These amendments are intended to implement Iowa Code section 155A.27 and 2015 Iowa Acts, Senate File 462.
These amendments will become effective on March 23, 2016.
The following amendments are adopted.
	Item 1. Amend subrule 6.10(1) as follows:
	6.10(1) Required information. The label affixed to or on the dispensing container of any prescription drug or device dispensed by a pharmacy pursuant to a prescription drug order shall bear the following:
	a.  and b.  No change.
	c. 	The Except as provided in 657—subrule 8.19(7) for epinephrine auto-injectors, the name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner;
	d.  to h.  No change.
	Item 2. Amend subrule 8.19(1) as follows:
	8.19(1) Requirements for a prescription. A valid prescription drug order shall be based on a valid patient-prescriber relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	a. 	Written, electronic, or facsimile prescription. In addition to the electronic prescription application and pharmacy prescription application requirements of this rule, a written, electronic, or facsimile prescription shall include:
	(1)	The date issued.
	(2)	The name and address of the patient except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	(3)	The name, strength, and quantity of the drug or device prescribed.
	(4)	The name and address of the prescriber and, if the prescription is for a controlled substance, the prescriber’s DEA registration number.
	(5)	The written or electronic signature of the prescriber.
	b.  to d.  No change.
	Item 3. Amend subrule 8.19(5) as follows:
	8.19(5) Legitimate purpose. The pharmacist shall ensure that the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner acting in the usual course of the practitioner’s professional practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued solely on the basis of an Internet-based questionnaire, an Internet-based consultation, or a telephonic consultation and without a valid preexisting patient-practitioner relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors.
	Item 4. Adopt the following new subrule 8.19(7):
	8.19(7) Epinephrine auto-injector prescription issued to school or facility. A physician, advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, or an accredited nonpublic school. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the facility, the school district, or the accredited nonpublic school in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.
	a. 	The pharmacy’s patient profile and record of dispensing of a prescription issued pursuant to this subrule shall be maintained in the name of the facility, school district, or accredited nonpublic school to which the prescription was issued and the drug was dispensed.
	b. 	The label affixed to an epinephrine auto-injector dispensed pursuant to this subrule shall identify the name and address of the facility, school district, or accredited nonpublic school to which the prescription is dispensed.
[Filed 1/28/16, effective 3/23/16]
[Published 2/17/16]
Editor’s Note: For replacement pages for IAC, see IAC Supplement 2/17/16.